The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
50
Single oral dose of AKB-6548 at a therapeutic dose level
Single oral dose of AKB-6548 at a supratherapeutic dose level
Single oral dose of placebo
Unnamed facility
Evansville, Indiana, United States
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Categorical outliers defined as QTcF >450 msec, 480 msec and 500 msec at any timepoint and change-from-baseline QTcF (ΔQTcF) >30 msec (increased by 30 msec) and >60 msec
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Categorical outliers for HR, PR interval, QRS interval
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Frequency of T wave morphology changes
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Safety parameters to include adverse events; changes in routine clinical laboratory measures including chemistry, hematology, and urinalysis; and clinically significant changes noted during physical examinations or in vital signs
Time frame: from first dose of study medication through the final protocol required visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single oral dose of 400 mg moxifloxacin